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The MyPlant II implants are surgically placed in the maxilla or mandible to enable prosthetic restorations in edentulous or partially edentulous patients. The implants are to be used exclusively prith MyPlason and and prosthetic components. The abutments serve for prosthetic restorations and can include individual crowns, bridges, partial or full prostheses. Abutments can be used for single tooth restorations or for the restoration of several teeth. The implants are intended for delayed loading with two surgical interventions. In castof oppriate primary stability (35 Ncm), immediate temporary restoration with appropriate occlusal load can also be appriverad.

The MyPlant II implant system serves as a tooth root substitute and can be used in free jaw sections or edentulous jaws. The MyPlant II implant is made of pure titanium Grade 4 (3.7065). The implant surface is micro-structured. The surface structure is created by blasting with white corundum (> 99 % AlsO3 = aluminum oxide) and etching with acid. Prosthetic connection and thus force transmission is conveyed via an internal cone. A sterile cover screw of 1 mm height is enclosed with each implant to enable an immediate occlusion of the internal thread after successful insertion. The implants are supplied sterile and are intended for single use. MyPlant II Implant System includes various implant variations with different diameters and lengths.

Dental abutments are used to support prosthetic reconstruction. Prosthetic applications can include individual crowns, bridges, partial or full prostheses. Abutments can be used for the replacement of one or more teeth. Depending on the indication and the anatomical conditions, the user will use several components for the specific prosthetic purpose. All components are made of a material suitable for the purpose of the application. The abutments are made of pure titanium Grade 4 (3.7065), titanium alloy Grade 5-ELI (Grade 23/3.7165), or PEEK. Except for the PEEK healing caps, the abutment surface is anodized. Connection to the implant is assured via an internal tapered connection as well as a metric thread. In the case of Abutments 0° / 15° and Shoulder Abutments, the abutment screw is not anodized and undergoes laser welding to connect the threaded sleeves with the shaft. The subject abutments are listed in a table with article number, description, and specifications.

The document provided is a 510(k) Premarket Notification from the FDA for the MyPlant II Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific acceptance criteria through a study with performance metrics.

Therefore, many of the requested details about acceptance criteria and study design are not explicitly available or applicable in the provided text. The document's purpose is to show that the new device is as safe and effective as a legally marketed one, not to independently prove its performance against a set of acceptance criteria in a quantitative sense with a large-scale clinical study that would yield metrics like sensitivity, specificity, or effect sizes for human readers.

However, I can extract information related to the non-clinical tests performed to demonstrate substantial equivalence, which can be seen as meeting certain underlying "acceptance criteria" for material, sterility, and mechanical performance.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of explicit acceptance criteria and corresponding reported device performance in the manner typically seen for diagnostic algorithms (e.g., sensitivity, specificity, F-score). Instead, it lists performance tests and validations conducted against established standards to demonstrate the safety and effectiveness of the dental implant system. The "performance" is reported as conformance to these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided in the context of this 510(k) submission. The document reports on non-clinical (laboratory) tests and relies on equivalence to predicate devices, rather than a clinical study with a "test set" of patients or data in the way an AI/software device would. The "samples" referred to are physical device components for testing (e.g., for fatigue, sterilization).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable/not provided. The ground truth for the non-clinical tests (e.g., successful sterilization, lack of cytotoxicity, fatigue resistance) is established by adherence to recognized international and national standards and validated laboratory procedures, not by expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable/not provided. Adjudication methods are typically relevant for clinical studies that involve human interpretation or subjective assessment. The tests performed are objective, based on standardized protocols.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable/not provided. The MyPlant II Implant System is a physical medical device (dental implants and abutments), not an AI/software device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with human readers (e.g., dentists, radiologists) and AI assistance is not relevant or described in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable/not provided. The device is a physical dental implant system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests is established by technical standards and validated laboratory methods. For example:

• Sterilization: Demonstrated sterility to a specified sterility assurance level (SAL).
• Biocompatibility: Absence of toxic effects as per ISO 10993.
• Fatigue: Resistance to fracture or failure under specified cyclic loading as per ISO 14801.

8. The sample size for the training set

This is not applicable/not provided. This document pertains to a physical medical device. The concept of a "training set" is relevant for AI/machine learning models, which are not the subject of this 510(k) submission.

9. How the ground truth for the training set was established

This is not applicable/not provided for the same reasons as point 8.

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Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.

The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

The Dental Implant System OKTAGON® Bone Level is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients.

The devices covered in this submission are angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level.

The abutments are made of Titanium Grade 4, the alligator abutments and screws are made of Titanium Alloy (TiAl6V4); the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.

This document is a 510(k) Summary for the Endosseous Dental Implant Abutments OKTAGON® Bone Level. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about acceptance criteria, study sizes, expert involvement, and ground truth types for AI/ML device studies is not applicable or not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for substantial equivalence based on predicate devices, explicit "acceptance criteria" for novel device performance are not listed in a quantifiable table as they would be for a new technology with specific performance claims. Instead, the "acceptance criteria" are implied by adherence to recognized standards and similarity to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Specific sample sizes for the mechanical and biocompatibility tests are not disclosed in this summary. The document states that "performance tests (breakage and fatigue tests) have been conducted," but does not provide the number of units tested.
• Data Provenance: Not specified. The manufacturer is Hager & Meisinger GmbH, located in Neuss, Germany. Testing was likely conducted in Germany or by certified labs.
• Retrospective or Prospective: Not specified, but typically, these types of laboratory tests for medical devices are conducted prospectively under controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable to this type of device submission. The device is a physical dental implant abutment, and its performance is evaluated through standardized material and mechanical testing, not through expert review of data like an AI/ML diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in evaluating clinical data or outputs of AI/ML systems where subjective interpretation might be involved. The testing here involves objective measurements against engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This information is not applicable to this type of device submission. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation enhanced by AI. This device is a physical implant component.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This information is not applicable to this type of device submission. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is based on established engineering and medical device standards. For example:
  • Mechanical Integrity: ISO 14801 (Fatigue Testing) and the FDA's Class II Special Controls Guidance document for dental implants.
  • Biocompatibility: ISO 10993-1, ISO 7405, ISO 10993-5.
  • Sterilization: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST 79.
  • Materials: ASTM F136, ASTM F67, ISO 5832-2, ISO 5832-3.
  • The "ground truth" is adherence to these normative standards and comparison to the characteristics of legally marketed predicate devices.

8. The sample size for the training set

• This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

9. How the ground truth for the training set was established

• This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

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